Label: LIDOCAINE- lidocaine hydrochloride injection, solution

INTRAVENOUS FOR CARDIAC ARRHYTHMIAS

Lidocaine hydrochloride, chemical name: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride has the following structural formula:

Lidocaine Hydrochloride Injection, USP intravenous for cardiac arrhythmias, is a sterile, nonpyrogenic solution prepared from lidocaine with the aid of hydrochloric acid in Water for Injection.

Each mL contains: Lidocaine HCl 20 mg; Sodium Chloride 6 mg; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 5.0 to 7.0). The container is for single use; solution contains no preservative.

Lidocaine hydrochloride exerts its antiarrhythmic effect by raising the electrical stimulation threshold of the ventricle during diastole. In usual therapeutic doses, lidocaine hydrochloride produces no change in myocardial contractility, systemic arterial pressure or in absolute refractory period.

Onset of action is rapid after an intravenous bolus with a duration of action of approximately 15 to 20 minutes.

Approximately 90% of an administered dose of lidocaine hydrochloride is metabolized in the liver. The remainder (10%) of the drug is excreted unchanged in the urine. Pharmacokinetic data indicate reduced elimination of lidocaine after prolonged (24 hours) infusion with resultant prolongation of the half-life to approximately three times that seen following a single administration.

Lidocaine Hydrochloride Injection, USP administered intravenously is specifically indicated in the acute management of 1) ventricular arrhythmias occurring during cardiac manipulation such as cardiac surgery, and 2) life-threatening arrhythmias, particularly those which are ventricular in origin, such as those which occur during acute myocardial infarction.

Lidocaine Hydrochloride Injection, USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine Hydrochloride Injection, USP should not be used in patients with STOKES-ADAMS syndrome, Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial, atrioventricular or intraventricular block.

Constant monitoring of the electrocardiogram and blood pressure is essential in the proper administration of Lidocaine Hydrochloride Injection, USP intravenously. If hypotension or excessive depression of cardiac conductivity (such as prolongation of the PR interval and QRS complex and the appearance of aggravation of arrhythmias) is seen, administration of Lidocaine Hydrochloride Injection, USP should be discontinued.

Emergency resuscitative equipment and drugs must be immediately available to manage possible adverse reactions involving the cardiovascular, respiratory, or central nervous system.

Occasional acceleration of ventricular rate may occur when Lidocaine Hydrochloride Injection, USP is administered to patients with atrial fibrillation.

Toxicity may be manifest as central nervous system depression (sedation) or irritability (twitching), which may progress to frank convulsions accompanied by respiratory depression and/or arrest. Early recognition of premonitory signs, assurance of adequate oxygenation and (where necessary) establishment of artificial airway with ventilatory support are essential to management of the problem. Should convulsions persist despite ventilatory support, small doses of anticonvulsant drugs may be used intravenously. Examples of such drugs include benzodiazepines (e.g., diazepam, lorazepam), or an ultrashort acting barbiturate (e.g., thiopental or thiamylal). If the patient is under anesthesia, a short-acting muscle relaxant (succinylcholine) may be used. Longer acting drugs should be used only when recurrent convulsions are evidenced.

The safe use of Lidocaine Hydrochloride Injection, USP requires careful ECG observation in an environment equipped and by persons trained for resuscitation.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Most adverse reactions accompanying administration of Lidocaine Hydrochloride Injection, USP result from systemic toxicity affecting primarily the central nervous system and the cardiovascular system.

Systemic reactions of the following types have been reported:

1. Central Nervous System

Light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred vision or double vision; vomiting; sensations of heat; cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest.

2. Cardiovascular System

Hypotension; cardiovascular collapse; and bradycardia which may lead to cardiac arrest. Continuous monitoring of blood pressure and the electrocardiogram are essential to prevent these events.

3. Allergic reactions may occur but are infrequent. There have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine and quinidine.

Management of Adverse Reactions—

1.

In the case of severe reaction, discontinue the use of Lidocaine Hydrochloride Injection, USP.

2.

Institute emergency resuscitative procedures and administer the emergency drugs necessary to manage the severe reaction. For severe convulsions, small increments of diazepam or an ultra short-acting barbiturate (thiopental or thiamylal); or if those are not available a short-acting barbiturate (pentobarbital or secobarbital); or if the patient is under anesthesia, a short-acting muscle relaxant (succinylcholine) may be given intravenously. Muscle relaxants and intravenous medications should only be used by those familiar with their use. Patency of the airway and adequacy of ventilation must be assured. (See WARNINGS.)

3.

Should circulatory depression occur, vasopressors, such as ephedrine, or meta raminol may be used. Should cardiac arrest occur, immediate initiation of standard CPR procedures should commence.

For Direct Injection Only

Lidocaine Hydrochloride Injection, USP

Preservative Free

Discard Unused Portion.

Use only if solution is clear and seal intact.

www.fresenius-kabi.com/us

45775D

Revised: May 2022

PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine HCl 5 mL Single Dose Vial Label

NDC 63323-208-01          20805

LIDOCAINE HCl

INJECTION, USP

2%

100 mg per 5 mL

(20 mg per mL)

Intravenous For

Cardiac Arrhythmias

Rx only

5 mL Single Dose Vial

PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine HCl 5 mL Vial Tray Label

NDC 63323-208-05          20805

LIDOCAINE HCl

INJECTION, USP

2%

100 mg per 5 mL

(20 mg per mL)

Intravenous For

Cardiac Arrhythmias

Rx only

25 Single Dose Vials, 5 mL